MAUDE Adverse Event Report: PENUMBRA, INC. POD PACKING COIL; HCG, KRD

Catalog Number	RBYPODJ30
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a pod packing coil (packing coil), a pod coil, and a lantern delivery microcatheter (lantern).It should be noted that the patient¿s anatomy was moderately tortuous and mildly calcified.During the procedure, the physician successfully implanted the pod coil into the target vessel using the lantern.While advancing the packing coil through the distal length of the lantern, the physician experienced resistance.As the physician was retracting the packing coil, the coil unintentionally detached within the lantern.Therefore, the lantern containing the detached packing coil was removed from the patient.The procedure was completed using a new packing coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil (packing coil) confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was fractured and the pull wire was retracted from the pusher assembly distal detachment tip.If the packing coil is advanced against resistance, damage such as a kink and subsequent fracture on the pusher assembly may occur.The pusher assembly fracture likely contributed to the pull wire to retract from the pusher assembly distal detachment tip and causing the embolization coil to detach during the procedure.The reported moderately tortuous and mildly calcified patient anatomy may have contributed to the resistance experienced during procedure.Further evaluation of the device revealed that the pet lock separated and pull tube was kinked on the proximal end of the pusher assembly.This damage is incidental to the complaint and the root cause could not be determined.Evaluation also revealed a kink on the pusher assembly and offset coil winds on the embolization coil.This damage is incidental to the reported complaint.The kink may have occurred during packaging of the device for return to penumbra.The offset coil winds may have occurred during manipulation of the packing coil against resistance.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21713569
• Report Number: 3005168196-2025-00095
• Device Sequence Number: 10010844
• Product Code: HCG
• UDI-Device Identifier: 00814548017655
• UDI-Public: 00814548017655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RBYPODJ30
• Device Lot Number: F00013884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male